Document Control Number: PQ-ED-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Device Inspection System in NDDS – Drug-Eluting Stents
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Device Inspection System operates within the defined parameters and meets the acceptance criteria for inspecting coating defects and dimensions of Drug-Eluting Stents.
Scope
This protocol applies to the Device Inspection System utilized in the QC/R&D area for the inspection of Drug-Eluting Stents. It covers the validation of the system’s performance and its ability to detect defects accurately.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- R&D/QC Personnel: Responsible for operating the Device Inspection System and reporting any deviations.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of calibration records for the Device Inspection System.
- Training of personnel on the operation of the Device Inspection System.
Equipment Description
The Device Inspection System (Vision/Microscopy) is designed to inspect coating defects and dimensions of Drug-Eluting Stents. It provides high-resolution imaging and measurement capabilities essential for quality control.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Calibration of detection accuracy | Calibration data integrity must be within ±5% of target values. | Calibration report and raw data. |
| PQ-02 | Testing detection of coating defects | Must detect ≥95% of known defects. | Test results and defect log. |
| PQ-03 | Measurement of dimensions | Measurements must be within specified tolerances. | Measurement report and verification log. |
Detailed Test Cases
Test Case PQ-01: Calibration of Detection Accuracy
Verify that the Device Inspection System calibration is accurate by comparing the output against known standards. Document any discrepancies.
Test Case PQ-02: Testing Detection of Coating Defects
Conduct a series of tests where known defects are introduced. Verify that the system detects at least 95% of these defects.
Test Case PQ-03: Measurement of Dimensions
Measure the dimensions of a sample of Drug-Eluting Stents and verify that the measurements fall within the specified tolerances.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented as necessary.
Approvals
Validation Team Lead: _____________________ Date: __________
Quality Assurance Manager: _____________________ Date: __________
“`